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Treatment of Calcific Total Occlusions in Peripheral Artery Disease

NCT05551780 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-06-13

No results posted yet for this study

Summary

Prospective, multi-center, non-randomized, open label, clinical study intended to provide data to demonstrate safety and performance of the SoundBite Crossing System XS Peripheral.

Conditions

  • Chronic Total Occlusion of Artery of the Extremities

Interventions

DEVICE

SoundBite Crossing System

Use of the SoundBite Crossing System to cross calcified chronic total occlusions

Sponsors & Collaborators

  • SoundBite Medical Solutions, Inc.

    lead INDUSTRY

Principal Investigators

  • George Adams, MD · UNC REX Hospital, Raleigh, NC, USA

  • Michael Lichtenberg, MD · Angiology Clinic and Vascular Centre, Arnsberg, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2024-11-30
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05551780 on ClinicalTrials.gov